NCT04971018

Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis Systemic Sclerosis

Impact of Transcutaneous Auricular Vagus Nerve Stimulation on Digestive Symptoms in Systemic Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of transcutaneous auricular vagus nerve stimulation (ta-VNS) on gastrointestinal symptoms and quality of life in systemic sclerosis (SSc) patients.

Detailed description

Conduct of study: Entry into the study: After informed consent, patients will be randomised into two arms (active or sham stimulation). The person responsible for setting the stimulator will make the randomization via an interactive web response system (IWRS). Only this person will have the knowledge of the group allocated to the patient. Start of ta-VNS sessions according to the 1st modality of stimulation : The patient will perform 2 stimulation sessions per day at home for 3 months. During this period a clinical research associate will contact the patient to verify that he does not encounter any problems with the stimulator. An evaluation visit will be carried out at the end of these three months by a blind physician. Wash-out period during 1 month. Start of ta-VNS sessions according to the 2nd modality of stimulation : The patient will perform 2 stimulation sessions per day at home for 3 months. An evaluation visit will be conducted prior to the start of the sessions and another at the end of the sessions.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DEVICE	Auricular vagus nerve stimulation	Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
DEVICE	Sham Auricular vagus nerve stimulation	Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.

Timeline

• Start date: 2021-11-09
• Primary completion: 2024-05-15
• Completion: 2024-06-01
• First posted: 2021-07-21
• Last updated: 2024-12-06

Locations

1 site across 1 country: France